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64Cu-ATSM PET/CT in Rectum Cancer (TEP 64Cu-ATSM-Rectum)

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ClinicalTrials.gov Identifier: NCT03951337
Recruitment Status : Recruiting
First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Sponsor:
Collaborator:
Fondation ARC
Information provided by (Responsible Party):
Institut Cancerologie de l'Ouest

Brief Summary:
This phase II trial is assessing how 64Cu-ATSM (64Cu-copper(II) diacetylbis(N4-methylthiosemicarbazone)) PET/CT scan could predict neo adjuvant treatment response in rectum cancer locally advanced

Condition or disease Intervention/treatment Phase
Rectal Cancer Drug: 64Cu-ATSM Phase 2

Detailed Description:

The purpose of this study is to evaluate early and late tumor uptake of 64Cu-ATSM in predicting histological response to neo-adjuvant chemo-radiotherapy treatment in patients with locally advanced rectal cancer.

Patients receive pre-therapeutic CT scan, Pelvic MRI and 18FDG (fluorodeoxyglucose) PET/CT (positron emission tomography) scan within 45 days before enrollment.

64Cu-ATSM PET/CT scan is done before chemoradiotherapy treatment start. About 3 MBq/Kg of 64Cu-ATSM are injected intravenously, two acquisition sequences are performed 1 hour and 23 to 25 hours after injection in order to evaluate early and late tumor uptake of 64Cu-ATSM.

Patients are treated for 5 weeks by Capecitabine chemotherapy (1600 mg/m2/day) combined to 50 Gy radiotherapy.

Pelvic MRI is performed 4 weeks after chemotherapy in order to evaluate the treatment efficacy.

Surgery is scheduled 6 to 8 weeks after chemoradiotherapy. Tissue samples from previously collected rectal biopsy (obtained for diagnosis) and from surgery are used for assessing oxidative stress markers by Immuno-histochemical analysis.

Chest, abdomen and pelvis CT scan is performed every 6 months after surgery in order to assess progression free survival.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Multicentric, open prospective study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of 64Cu-ATSM PET/CT in Predicting Neo Adjuvant Treatment Response in Locally Advanced Rectum Cancer
Actual Study Start Date : April 26, 2019
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Arm Intervention/treatment
Experimental: 64Cu ATSM
pretherapeutic 64Cu-ATSM PET/CT scan
Drug: 64Cu-ATSM
64 Cu-ATSM PET/CT scan




Primary Outcome Measures :
  1. Relationship between early tumor uptake of 64Cu-ATSM PET/CT images and prediction of histological response to neo-adjuvant chemo-radiotherapy treatment [ Time Frame: 4 months ]
    Early tumor uptake of 64Cu-ATSM will be assessed by SUV (Standardized Uptake Value) measurement, histological response Will be assessed by Rodel grading (Tumor Regression Grading)


Secondary Outcome Measures :
  1. Relationship between late tumor uptake of 64Cu-ATSM PET/CT images and prediction of histological response to neo-adjuvant chemo-radiotherapy treatment [ Time Frame: 4 months ]
    Late tumor uptake of 64Cu-ATSM will be assessed by SUV (Standardized Uptake Value) measurement, histological response Will be assessed by Rodel grading (Tumor Regression Grading)

  2. Correlation between 64Cu-ATSM uptake and oxidative stress markers [ Time Frame: 4 months ]
    Aggressive zones corresponding to high redox potential areas will be assessed by Immuno-histochemical analysis on the surgical sample and on the pre-therapeutic biopsy

  3. Progression free survival [ Time Frame: 2 years ]
    Progression Free survival is the delay between surgery and the date of documented disease progression

  4. 18FDG-PET/CT and 64Cu-PET/CT uptakes [ Time Frame: 45 days ]
    Correlation between 18FDG-PET/CT and 64Cu-PET/CT uptakes

  5. Comparison between early and late 64Cu-ATSM uptakes in 64Cu-ATSM PET/CT images [ Time Frame: 45 days ]
    Early and Late tumor uptake of 64Cu-ATSM will be assessed by SUV (Standardized Uptake Value) measurement

  6. 64Cu-ATSM toxicity [ Time Frame: 45 days ]
    64Cu-ATSM toxicity will be assessed by vital signs monitoring within 2 hours after 64Cu-ATSM injection



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed rectum adenocarcinoma
  • Locally advanced, non metastatic disease, with or without locoregional lymph node involvement (greater than or equal to T3 +/- N), first-line therapy
  • 18 Years and older
  • Performance Status equal to 0 or 1
  • Fertile patients must use effective contraception
  • Hemoglobin greater than 9g/dl, neutrophils greater than 1 500/mm3, platelets greater than 100 000/mm3
  • Creatinine clearance greater than or equal to 50ml/min
  • Plan to receive treatment with concurrent chemotherapy and radiation therapy followed by surgery
  • Totality of the tumor included in the radiotherapy field
  • Written informed consent
  • Patient must be affiliated to a Social Health Insurance

Exclusion Criteria:

  • metastatic disease
  • Patient contraindicated for capecitabine or 5FU (5-Fluoro-Uracile) derivatives (history of severe and unexpected reactions to fluoropyrimidine-containing therapy, known hypersensitivity to 5FU, to any of the excipients, or known total DPD (dihydropyrimidine déshydrogénase) deficiency)
  • Known Contraindication to perform MRI
  • Previous treatment with pelvic radiotherapy
  • Chronic inflammatory bowel disease, malabsorption, lack of colonic integrity
  • Diarrhea grade greater than 2
  • Contraindication to surgery
  • Bilateral total hip prosthesis
  • Other malignancy treated within the last 5 years (except non-melanoma skin cancer or in situ carcinoma of the cervix)
  • Pregnant or nursing patient
  • Individual deprived of liberty or placed under the authority of a tutor
  • Impossibility to submit to the medical follow-up of this clinical trial for geographical, social or psychological reasons
  • Agitation; impossibility of lying motionless for at least 1 hour, or known claustrophobia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951337


Contacts
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Contact: Mathilde COLOMBIE, MD +33240679900 ext 9501 mathilde.colombie@ico.unicancer.fr
Contact: Nadia FLEURY, PhD +33240679900 ext 9168 nadia.fleury@ico.unicancer.fr

Locations
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France
Institut de Cancerologie de l'Ouest (ICO) Not yet recruiting
Angers, France, 49055
Contact: Mathilde COLOMBIE, MD    +33240679900 ext 9501    mathilde.colombie@ico.unicancer.fr   
Principal Investigator: Mathilde COLOMBIE, MD         
CHU de BREST Not yet recruiting
Brest, France, 29200
Contact: Pierre Yves SALAUN, MD, PhD    +33298223117    pierre-yves.salaun@chu-brest.fr   
Principal Investigator: Pierre Yves SALAUN, MD, PhD         
Centre Eugene Marquis Not yet recruiting
Rennes, France, 35045
Contact: Anne DEVILLERS, MD    +33299253084    a.devillers@rennes.unicancer.fr   
Principal Investigator: Anne DEVILLERS, MD         
Institut de cancerologie de l'Ouest Recruiting
Saint Herblain, France, 44805
Contact: Mathilde COLOMBIE, MD    +33240679900 ext 9501    mathilde.colombie@ico.unicancer.fr   
Principal Investigator: Mathilde COLOMBIE, MD         
Sponsors and Collaborators
Institut Cancerologie de l'Ouest
Fondation ARC
Investigators
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Principal Investigator: Mathilde COLOMBIE, MD Institut de Cancerologie de l'Ouest

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Responsible Party: Institut Cancerologie de l'Ouest
ClinicalTrials.gov Identifier: NCT03951337     History of Changes
Other Study ID Numbers: ICO-N-2017-14
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institut Cancerologie de l'Ouest:
64Cu-ATSM
neoadjuvant treatment
chemoradiotherapy
surgery
Positron Emission Tomography (PET)/CT scan
Prediction of response to treatment
Rodel score

Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases